NCT05703906CompletedNot Applicable
Teleneurorehabilitation for the Continuity of Care Post-stroke: a Multicentric Pilot Study
IRCCS San Camillo, Venezia, Italy2 sites in 1 country84 target enrollmentStarted: March 16, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 84
- Locations
- 2
- Primary Endpoint
- Feasibility of telerehabilitation system
Study Overview
Brief Summary
The main aim of this longitudinal, pilot study is to evaluate the feasibility of a multi-domain (i.e., motor, language and cognitive domains) telerehabilitation system using the Virtual Reality Rehabilitation System (VRRS, Khymeia) in patients with stroke. Furthermore, data on patients' needs and clinical data will be collected before and after treatment and then analyzed.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Single ischemic stroke documented by CT/ MRI;
- •2 to 18 months after the event.
Exclusion Criteria
- •medical history or presence of cognitive decline (MoCA<17.54)
- •recent fractures
- •History of mental disorders (major depression, psychosis)
- •History/presence of other neurological disorders that may interfere with outcome
- •Presence of other internal pathologies that may interfere with outcome or treatment
Outcomes
Primary Outcomes
Feasibility of telerehabilitation system
Time Frame: 6 weeks
Feasibility will be measured by calculating the adherence to treatment (i.e. percentage of training sessions completed).
Secondary Outcomes
- Change in caregiver burden(Baseline up to 6 weeks)
- Change in Independence (Activities of Daily Living)(Baseline up to 6 weeks)
- Satisfaction of the treatment(6 weeks)
- Change in linguistic functions(Baseline up to 6 weeks)
- Change in behavior (depression)(Baseline up to 6 weeks)
- Change in motor functions(Baseline up to 6 weeks)
- Change in cognitive functions(Baseline up to 6 weeks)
- Change in measure of quality of life(Baseline up to 6 weeks)
Investigators
Study Sites (2)
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